Reaction mass of 1,1'-oxybis(ethylbenzene) and Styrene, oligomers

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014-2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD and GLP guidelines, and was considered to be relevant, adequate and reliable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: The Ocular Toxicity Working Group (OTWG) of the ICCVAM and the(NICEATM),Background Review Document (BRD): current status of in vitro test methods for identifying ocular corrosives and severe irritants: The BCOP Test Method, March 2006.

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: In Vitro Techniques in Toxicology Database (INVITTOX) protocol 127. Bovine Opacity and Permeability (BCOP) Assay, 2006.

Deviations:

no

Test guideline 5

Qualifier:

according to guideline

Guideline:

other: Gautheron P., Dukic M., Alix D. and Sina J.F., Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy. Fundam Appl Toxicol 18:442-449, 1992.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (1,1’ oxybis(ethylbenzene) and styrene, oligomers

IUPAC Name:

Reaction mass of (1,1’ oxybis(ethylbenzene) and styrene, oligomers

Constituent 2

Reference substance name:

SMPO Heavy Ends

IUPAC Name:

SMPO Heavy Ends

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): SMPO Heavy Ends; Reaction mass of (1,1’ oxybis(ethylbenzene) and styrene, oligomers

- Substance type: UVCB
- Physical state: Brown liquid
- Analytical purity: 100%
- Purity test date: No data
- Lot/batch No.: BC604 17-10-2014
- Expiration date of the lot/batch: No data
- Stability under test conditions: Not indicated
- Storage condition of test material: At room temperature protected from light

Test animals / tissue source

Species:

other: in vitro

Test system

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL undiluted

Results and discussion

In vivo

Results

Irritation parameter:

other: mean IVIS (in vitro irritancy score)

Basis:

mean

Time point:

other: 10 minutes

Score:

17.9

Remarks on result:

other: 17.9 >3; = 55: no prediction on the classification can be made.

Any other information on results incl. tables

SMPO Heavy Ends was tested neat.

Table 1 summarizes the opacity, permeability and in vitro irritancy scores of SMPO Heavy Ends and the controls. The opacity, permeability and in vitro scores of the individual corneas are shown in Table 2-5.

The individual in vitro irritancy scores for the negative controls ranged from -3.0 to 1.0. The individual positive control in vitro irritancy scores ranged from 131 to 153 for Benzalkonium Chloride. The corneas treated with the positive control substance were turbid after the 10 minutes of treatment.

The corneas treated with SMPO Heavy Ends showed opacity values ranging from 14 to 17 and permeability values ranging from 0.018 to 0.465. The corneas were turbid after the 10 minutes of treatment with SMPO Heavy Ends. No pH effect of the test substance was observed on the rinsing medium, however the test substance was difficult to remove. Hence, the in vitro irritancy scores ranged from 15.5 to 21.0 after 10 minutes of treatment with SMPO Heavy Ends.

The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas.

The mean in vitro irritancy score of the positive control (10% (w/v) Benzalkonium Chloride) was 144 and was within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

SMPO Heavy Ends induced ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 17.9 after 10 minutes of treatment.

Since SMPO Heavy Ends induced an IVIS > 3 = 55, no prediction on the classification can be made.

 

Table 1. Summary of opacity, permeability andin vitroscores

Treatment	Mean Opacity^1	Mean Permeability^1	Mean In vitro Irritation Score^1, 2
Negative control	-1	0.000	-0.7
Positive control (Benzalkonium Chloride)	91	3.571	144.2
SMPO Heavy Ends	15	0.172	17.9

 

¹Calculated using the negative control mean opacity and mean permeability values.

²In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).

 

Table 2. Opacity score

Eye	Opacity before treatment	Opacity after treatment	Final Opacity^1	Negative control corrected Final Opacity^2	Mean Opacity
Negative control
1	3	0	-3	-3	-1
2	0	0	0	0
3	3	4	1	-1
		Mean final opacity: -1
Positive control
4	1	86	85	85	91
5	1	106	105	105
6	1	83	82	82
SMPO Heavy Ends
16	0	14	14	14	15
17	2	17	15	15
18	0	17	17	17

 

¹Final Opacity = Opacity after treatment – Opacity before treatment.

²Negative control corrected Final Opacity = Final opacity – Mean final opacity negative control.

 

Table 3. Permeability score individual values (uncorrected)

Eye	Dilution factor	OD490 1	OD490 2	OD490 3	Average OD	Final OD^1	Mean final negative control
Negative control
1	1	0.006	0.012	0.004	0.007	0.007	0.007
2	1	0.005	0.005	0.006	0.005	0.005
3	1	0.009	0.008	0.009	0.009	0.009
Positive control (Benzalkonium Chloride)
4	6	0.520	0.522	0.524	0.522	3.132
5	6	0.525	0.468	0.470	0.488	2.926
6	6	0.795	0.790	0.806	0.797	4.782
SMPO Heavy Ends
16	1	0.477	0.464	0.474	0.472	0.472
17	1	0.039	0.041	0.040	0.040	0.040
18	1	0.025	0.025	0.025	0.025	0.025

 

¹Final OD = Average OD x Dilution factor.

 

Table 4. Permeability score individual values (corrected)

Eye	Dilution factor	Negative control corrected OD490 1^1	Negative control corrected OD490 2^1	Negative control corrected OD490 3^1	Negative control corrected OD490 Average	Negative control corrected final OD490	Average OD
Negative control
1	1	-0.001	0.005	-0.03	0.000	0.000	0.000
2	1	-0.002	-0.002	-0.01	-0.002	-0.002
3	1	0.002	0.001	0.002	0.002	0.002
Positive control (Benzalkonium Chloride)
4	6	0.513	0.515	0.517	0.515	3.089	3.571
5	6	0.518	0.461	0.463	0.481	2.883
6	6	0.788	0.783	0.799	0.790	4.739
SMPO Heavy Ends
16	1	0.470	0.457	0.467	0.465	0.465	0.172
17	1	0.032	0.034	0.033	0.033	0.033
18	1	0.018	0.018	0.018	0.018	0.018

 

¹OD490 values corrected for the mean final negative control permeability (0.007).

 

 

Table 5.In vitroirritancy score

Eye	Negative control corrected Final Opacity	Negative control corrected Final OD490	In vitroIrritancy Score^1
Negative control
1	-3	0.000	-3.0
2	0	-0.002	0.0
3	1	0.002	1.0
Positive control (Benzalkonium Chloride)
4	85	3.089	131.3
5	105	2.883	148.3
6	82	4.739	153.1
SMPO Heavy Ends
16	14	0.465	21.0
17	15	0.033	15.5
18	17	0.018	17.3

 

¹In vitro irritancy score (IVIS) = opacity value + (15 x OD490 value).

Applicant's summary and conclusion

Interpretation of results:

other: no prediction on the classification can be made

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

Since SMPO Heavy Ends induced an IVIS > 3 = 55, no prediction on the classification can be made in this BCOP test .

Executive summary:

Screening for the eye irritancy potential of SMPO Heavy Ends using the Bovine Corneal Opacity and Permeability test (BCOP test).The substance was tested through topical application for 10 ± 1 minutes. Batch BC604 14-10-2014 of SMPO Heavy Ends was a brown liquid with a purity of 100%. The test substance was applied as it is (750 µL) directly on top of the corneas.

The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (10% w/v) Benzalkonium Chloride) was 144 and was within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

SMPO Heavy Ends induced ocular irritation throughout both endpoints, resulting in a mean in vitro irritancy score of 17.9 after 10 minutes of treatment. Since SMPO Heavy Ends induced an IVIS > 3 = 55, no prediction on the classification can be made.